Does Rehabilitation After Total Knee Arthroplasty Work? - Feasibility Trial
A legfontosabb adatok
- Ki végzi
- Copenhagen University Hospital, Hvidovre
- Hol
- Dánia2 helyszín, 1 országbanVálassz országot a helyszínekhez
- Azonosító
- Állapot
- Befejeződött
- Résztvevők
- 25 fő vett részt
- Kezdés
- 2023. aug. 22.
- Befejezés
- 2024. szept. 10.
- A vizsgálat típusa
- Beavatkozással járó, 2 csoportAz egyik csoport egy már használt kezelést kap, összehasonlításként.
- A vizsgált kezelések
- Usual care - Municipal exercise-based rehabilitation
- Return to Everyday life
- Symptom guide and encouragement to follow DHA/WHO recommendations for physical activity
- A regiszteradat frissítve
- 2025. július 9.
Ki vehet részt
- Életkor
- 18 év felett
- Nem
- Nők és férfiak
- Egészséges önkéntesek
- Nem vehetnek részt
A regiszter feltételei, szó szerint
Mind a 6 feltétel megnézéseKevesebb
Ki vehet részt
- Over 18 years of age
- Residing in one of fourteen collaboration municipalities
- Referral to primary total knee arthroplasty for osteoarthritis
Ki nem vehet részt
- Severe surgical sequelae (i.e. requiring revision surgery, joint mobilization under anaestesia, or joint infection)
- Insufficient danish skills (read/write/speak) to understand questionnaires and outcomes
- Inability to provide informed consent
Ennek a vizsgálatnak nincs helyszíne itt: Egyesült Államok.
Egy országban van helyszíne. Válassz országot, hogy lásd a helyszíneket.
A vizsgálatról
Mit akar kideríteni a vizsgálat
The aim of this feasibility trial is to investigate the feasibility of a trial intervention for a population of patients after total knee replacement for osteoarthritis. This study follows a hybrid type 1 design where the primary focus is on the feasibility of the intervention, and the secondary focus is on gaining a better understanding of context and acceptability.
A teljes eredeti leírásKevesebb
The main questions it aims to answer are:
* Recruitment (Process/Resources): Are patients willing to engage, and stay, in the trial (estimated by inclusion-rate, participant retention, etc.) and what reasons do patients give for not wishing to enroll or later dropping out of the trial? (inquired face-to-face, during enrolment). * Harms (Scientific): Does the non-exercise intervention appear "safe" (i.e. not harmful) for the patients? (estimated by for instance: adverse events, reasons for dropouts and sense of security). * Trial procedure feasibility (Management/Scientific): How well does recruitment and trial procedures work at trial sites? (estimated through feedback from site personnel). * Participant (patient) experienced acceptability of their assigned intervention: An interview-based follow-up using the Theoretical Framework of Acceptability.
Participants will be randomized to one of two interventions, at discharge from the hospital, following knee replacement, which are being tested for feasibility:
1. "Usual-care" - referral to municipal (free-of-charge) physiotherapy (commonly 6-8 weeks of therapeutic exercise). 2. "Return to everyday life" - no referral to municipal physiotherapy.
Participants in both groups are encouraged to follow WHO guidelines of physical activity, to the degree that their post-surgical symptoms allow (within their orthopedic surgeon's recommendations/limitations). All participants are given a "symptom guide", meaning a folder containing information on what to expect, and when and what to react to, during their recovery after the knee-replacement.
For clarity it should be mentioned, that the quantitative and qualitative data-outputs will be reported separately for improved clarity (the study is not a mixed methods design).
A vizsgálat 2 csoportja
- Usual CareMár használt kezelés, összehasonlításként
Referral to municipal rehabilitation after TKA
Kezelés: Usual care - Municipal exercise-based rehabilitation és Symptom guide and encouragement to follow DHA/WHO recommendations for physical activity
- Return to Everyday LifeEgyéb csoport
No referral to municipal rehabilitation after TKA
Kezelés: Return to Everyday life és Symptom guide and encouragement to follow DHA/WHO recommendations for physical activity
Adatok és források
- Regiszteradat
- Szerepel a ClinicalTrials.gov-on.
- Hivatalos cím
- Feasibility of a Randomized Trial Comparing Exercise-based Rehabilitation With Non-exercise-based Recovery After Total Knee Arthroplasty; DRAW-TKA Hybrid 1 Feasibility Trial
- Publikációk
- A regiszteradat frissítve
- 2025. július 9.